NCT03838900

Brief Summary

An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the Loop DIY automated insulin delivery system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 17, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

November 21, 2018

Last Update Submit

August 12, 2020

Conditions

Diabetes Mellitus, Type 1

Keywords

LoopRileyLinkType 1 Diabetes

Outcome Measures

Primary Outcomes (3)

  • Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events

    Number of DKA events and event outcomes on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider.

    6 Months

  • Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events

    Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.

    6 Months

  • Measure of Loop Safety by Self-Report of Hospitalization Events

    Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.

    6 Months

Secondary Outcomes (3)

  • Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events

    12 Months

  • Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events

    12 Months

  • Measure of Loop Safety by Self-Report of Hospitalization Events

    12 Months

Other Outcomes (15)

  • Loop Baseline General Data Collection

    Enrollment

  • Summary statistics for CGM metrics

    6 months and 12 months

  • Loop Additional Form for Current Loop Users

    Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months

  • +12 more other outcomes

Study Arms (2)

Cohort A

Individuals who have not started Loop or who have been on Loop fewer than 7 days at the time of enrollment.

Device: Loop

Cohort B

Participants who have been using Loop 7 or more days at the time of enrollment.

Device: Loop

Interventions

LoopDEVICE

The Loop System consists of an insulin pump (certain versions of Medtronic insulin pumps) and a Dexcom or Medtronic CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.

Cohort ACohort B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals using or planning to use the Loop system

You may qualify if:

  • Type 1 diabetes
  • Currently have, or have ordered, the hardware devices necessary to use Loop
  • Currently use Loop or have plans to start using Loop for insulin delivery
  • Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data and complete questionnaires that are part of the protocol
  • Resident of U.S.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location

Related Publications (2)

  • Suttiratana SC, Wong JJ, Lanning MS, Dunlap A, Hanes SJ, Hood KK, Lal RA, Naranjo D. Qualitative Study of User Experiences with Loop, an Open-Source Automated Insulin Delivery System. Diabetes Technol Ther. 2022 Jun;24(6):416-423. doi: 10.1089/dia.2021.0485. Epub 2022 May 12.

    PMID: 35099278DERIVED

  • Wong JJ, Suttiratana SC, Lal RA, Lum JW, Lanning MS, Dunlap A, Arbiter B, Hanes SJ, Bailey RJ, Hood KK, Naranjo D. Discontinued Use of the Loop Insulin Dosing System: A Mixed-Methods Investigation. Diabetes Technol Ther. 2022 Apr;24(4):241-248. doi: 10.1089/dia.2021.0362.

    PMID: 34780283DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • John Lum, MS

    Jaeb Center for Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

February 12, 2019

Study Start

January 17, 2019

Primary Completion

March 31, 2020

Study Completion

April 25, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

US(1)